Milestones


CLINICAL TRIALS

  • The Company is currently pursuing a clinical trial of the Optimum TAVI system in Europe.
  • Labcor Laboratórios, one of the Company’s license partners, began a clinical trial of the Optimum TAVI system in Brazil in 2018.
  • Wide Line (China Cardiovascular Research Foundation), another license partner of the Company, is planning to start a clinical trial of the Optimum TAVI system in China in 2022.

FIRST-IN-HUMAN EXPERIENCE

  • Successfully completed the First-in-Human implant of the Optimum TAV in a patient with severe aortic stenosis in December 2018, officially launching a clinical trial in Brazil sponsored by Labcor Laboratórios.
  • The Optimum TAV was implanted percutaneously through the femoral artery using the Optimum TAVI delivery system. The patient experienced no complications in the procedure, and the valve functioned well with favorable hemodynamic performance and no paravalvular leakage.
  • Clinical efficacy and successful valve hemodynamic performance have now been demonstrated at over 2 years. The patient is experiencing no symptoms and doing very well.

ANIMAL STUDIES

  • Completed feasibility studies of Optimum TAV and the delivery system in 6 chronic and 8 acute sheep, and 1 chronic pig.
  • Implanted Optimum TAV in the aortic position, in the brachiocephalic artery, and in the descending aorta. Optimum TAV and the delivery system worked well. Optimum TAV stayed in place and showed normal function, with good healing and no adverse reactions.
  • In 4 sheep, with our valve in the aortic position for 90, 145, 145, and 161 days, the data on the pressure gradient and valve function looks extraordinary, and superior to any data published on a TAV.

Deployment of Optimum TAV

Deployment of Optimum TAV

Angiogram showing there is no leakage through Optimum TAV

Angiogram showing there is no leakage through Optimum TAV

DURABILITY TEST

  • Optimum TAV has completed more than 890 million cycles with ΔP ≥ 100mm Hg, surpassing the ISO/FDA required 200 million cycles.

LICENSE AGREEMENTS

  • Executed a license agreement with Labcor Laboratórios to fully sponsor a clinical trial of the Optimum TAVI system in Brazil, and commercialize throughout South America in exchange for clinical data and a royalty.
  • Executed a license agreement with Wide Line to fully sponsor a clinical trial of the Optimum TAVI system in China, and commercialize in Mainland China and surrounding areas in exchange for clinical data and a royalty.

PATENTS

  • Multiple patents for Optimum TAV granted in the US and Canada, and pursued in Europe. Patent directed to catheter-delivery system filed in 2019 and favorable written opinion obtained in October 2019.

HYDRODYNAMIC TEST

  • Demonstrated an Effective Orifice Area of 2.1 cm² for Optimum TAV (compared to 1.9 cm² for the surgical valve used as a control).

HUMAN CADAVER HEART STUDIES

  • Implanted 2 cadaver hearts with Optimum TAV frames. These experiments closely represent the implant of Optimum TAV in Aortic Stenosis (AS) patients since the cadaver hearts had mild to moderate AS. In both cases, Optimum TAV’s frames were implanted below the coronary ostia and above the left bundle branch, and did not impinge on the mitral valve. The frames were delivered to the correct position repeatedly using the Company’s delivery system and were anchored firmly in place; significant force could not move them.

FRAME FATIGUE TEST

  • Completed finite element analysis studies of frame fatigue.